- Comprehensive results from Phase 3
ARIEL3 maintenance treatment trial of rucaparib in advanced ovarian
cancer patients accepted as late-breaker presentation, will be
highlighted in ESMO press program
- Posters outlining the designs of the
ARIEL4 and TRITON clinical trial programs will also be
presented
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that
abstracts highlighting progress in the rucaparib clinical
development program will be presented at the 2017 European Society
for Medical Oncology (ESMO) Congress taking place September 8-12,
2017 in Madrid, Spain. These abstracts include a late breaker oral
presentation that serves as the first academic presentation of an
expanded dataset from the ARIEL3 clinical study.
ARIEL3 is a double-blind, placebo-controlled, phase 3 trial of
rucaparib that enrolled 564 women with platinum-sensitive,
high-grade ovarian, fallopian tube, or primary peritoneal cancer.
Topline data announced in June 2017 demonstrate that ARIEL3
successfully achieved the primary endpoint of improved progression
free survival by investigator review and blinded independent
central review (BICR) in each of the three populations studied:
tumor BRCA-mutant, HRD-positive and overall intent-to-treat
populations. The safety of rucaparib observed in ARIEL3 was highly
consistent with the U.S. treatment label for rucaparib. The
September 8 ESMO presentation will provide comprehensive, detailed
results of each ARIEL3 endpoint, along with a summary of safety
data.
Additionally, two abstracts will provide an overview of the
background and clinical trial design for the ongoing ARIEL4 study
of rucaparib in ovarian cancer and the TRITON2 and TRITON3 studies
of rucaparib in prostate cancer. These studies are evaluating
rucaparib in germline and somatic BRCA-mutated, relapsed,
high-grade ovarian cancer, and in metastatic castration-resistant
prostate cancer associated with homologous recombination
deficiency, respectively.
“We look forward to presenting the comprehensive dataset from
our ARIEL3 clinical trial, which demonstrates rucaparib’s
clinically meaningful benefit in the maintenance setting for women
with platinum-sensitive, advanced ovarian cancer,” said Patrick J.
Mahaffy, President and CEO of Clovis Oncology. “It has become
increasingly clear that PARP inhibitors have a significant role to
play in the current and future cancer-treatment paradigm, as
monotherapy and potentially in combination with other therapeutic
agents. The abstracts being presented at ESMO 2017 highlight our
commitment to leveraging the very exciting potential of rucaparib
in the fight against prostate and ovarian cancer, both devastating
diseases for which we hope rucaparib may be able to offer new hope
to patients and physicians.”
The three rucaparib abstracts accepted for presentation at the
2017 ESMO congress comprise:
Abstract LBA40– ARIEL3: A Phase 3, Randomised,
Double-Blind Study of Rucaparib vs Placebo Following Response to
Platinum-Based Chemotherapy for Recurrent Ovarian Carcinoma
(OC)Presenter: Professor Jonathan A. Ledermann, MD,
University College London Cancer Institute and University College
London Hospitals, UKSession: Proffered paper session,
Gynecological CancersDate/Time: Friday, September 8,
16:12-16:24 CESTLocation: Cordoba AuditoriumThis abstract
will also be featured in the ESMO press program from 08:15–09:00
CEST on Sunday, 10 September in Hall 10.
Abstract 988TIP – ARIEL4: An International, Randomised
Phase 3 Study of the PARP Inhibitor Rucaparib vs Chemotherapy for
the Treatment of BRCA-Mutated, Relapsed, High-Grade Ovarian
CancerPresenter: Dr. Rebecca S. Kristeleit, MD, University
College London Cancer Institute, UKSession: Poster
sessionDate/Time: Saturday, September 9, 13:15-14:15
CESTLocation: Hall 8
Abstract 836TIP – The TRITON Clinical Trial Program:
Evaluation of the PARP Inhibitor Rucaparib in Patients (Pts) with
Metastatic Castration-Resistant Prostate Cancer (mCRPC) Associated
with Homologous Recombination Deficiency (HRD)Presenter: Dr.
Simon Chowdhury, MD, Guy’s Hospital & Sarah Cannon Research
Institute, UKSession: Poster sessionDate/Time:
Sunday, September 10, 13:15-14:15 CESTLocation: Hall 8
Clovis’ rucaparib presentations and posters will be available
online
at http://clovisoncology.com/pipeline/scientific-presentations/
as of the time they are presented at the meeting.
Investor/Analyst Briefing and Webcast
Clovis Oncology, Inc. will webcast an investor and analyst
briefing in Madrid on Saturday, September 9 at 6:00 PM CEST in
conjunction with the ESMO annual meeting. At this briefing, Clovis
Oncology management will review the rucaparib development program
and data presented at ESMO and answer questions from investors and
analysts. This event will be webcast live and archived for 30 days,
and may be accessed from the Clovis Oncology Investor Events and
Presentations webpage at www.clovisoncology.com. The
presentation will begin at 6:00 PM CEST for those institutional
investors and analysts attending this event in Madrid; please RSVP
to meetings@clovisoncology.com to attend.
About Rucaparib
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2
and PARP3 being developed in ovarian cancer as well as several
additional solid tumor indications. In December 2016, rucaparib
became the first PARP inhibitor approved by the U.S. Food and Drug
Administration (FDA) as monotherapy for treatment of patients with
deleterious BRCA mutation (germline and/or somatic) associated
advanced ovarian cancer who have been treated with two or more
prior chemotherapies. During the fourth quarter of 2016, the
Marketing Authorization Application (MAA) submission in Europe for
rucaparib in the same ovarian cancer treatment indication was
submitted and accepted for review. By the end of October 2017,
Clovis Oncology intends to submit a supplemental New Drug
Application (sNDA) in the U.S. for a second line or later
maintenance treatment indication in ovarian cancer based on the
ARIEL3 data, and in early 2018, plans to file an MAA in Europe for
the maintenance treatment indication upon receipt of a potential
approval for the treatment indication. Studies open for enrollment
or under consideration include ovarian, prostate, breast,
pancreatic, gastroesophageal, bladder, lung and urothelial cancers.
Clovis is also developing rucaparib in patients with mutant BRCA
tumors and other DNA repair deficiencies beyond BRCA – commonly
referred to as homologous recombination deficiencies, or HRD.
Clovis holds worldwide rights for rucaparib.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company
focused on acquiring, developing and commercializing innovative
anti-cancer agents in the U.S., Europe and additional
international markets. Clovis Oncology targets
development programs at specific subsets of cancer populations, and
simultaneously develops, with partners, diagnostic tools intended
to direct a compound in development to the population that is most
likely to benefit from its use. Clovis Oncology is
headquartered in Boulder, Colorado, and has additional offices
in San Francisco, California and Cambridge, UK.
Please visit clovisoncology.com for more information.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis Oncology,
they are forward-looking statements reflecting the current beliefs
and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Examples of forward-looking statements contained in this press
release include, among others, statements regarding our expectation
of timing for submission of the sNDA for rucaparib to the FDA, our
expectations for regulatory developments in the EU with respect to
rucaparib and our future development plans. Such forward-looking
statements involve substantial risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from that expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, the
uncertainties inherent in the clinical development programs for our
drug candidates, including the result of clinical trials, whether
future study results will be consistent with study findings
to-date, the corresponding development pathways of our companion
diagnostics, the timing of availability of data from our clinical
trials and the results of our clinical trials, the initiation,
enrollment and timing of our planned clinical trials, actions by
the FDA, the EMA or other regulatory authorities regarding
whether to approve drug applications that may be filed, as well as
their decisions that may affect drug labeling, pricing and
reimbursement, and other matters that could affect the availability
or commercial potential of our drug candidates or companion
diagnostics. Clovis Oncology does not undertake to update or
revise any forward-looking statements. A further description of
risks and uncertainties can be found in Clovis Oncology’s filings
with the Securities and Exchange Commission, including its Annual
Report on Form 10-K and its reports on Form 10-Q and Form 8-K.
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version on businesswire.com: http://www.businesswire.com/news/home/20170830005228/en/
Clovis OncologyInvestor Contacts:Anna Sussman,
+1-303-625-5022asussman@clovisoncology.comorBreanna Burkart,
+1-303-625-5023bburkart@clovisoncology.comorClovis Media
Contacts:USLisa Guiterman,
+1-301-217-9353clovismedia@sambrown.comorChristy Curran,
+1-615-414-8668clovismedia@sambrown.comorEUAnn Hughes, +44
(0)7944-168-187Ann.Hughes@publicisresolute.com
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